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维生素E对类风湿关节炎患者甲氨蝶呤所致肝毒性的疗效:一项开放标签病例对照研究。

Efficacy of Vitamin E in Methotrexate-Induced Hepatotoxicity in Rheumatoid Arthritis: An Open-Label Case-Control Study.

作者信息

Vaidya Binit, Bhochhibhoya Manisha, Nakarmi Shweta

机构信息

National Center for Rheumatic Diseases (NCRD), Kathmandu, Nepal.

出版信息

Int J Rheumatol. 2020 May 1;2020:5723485. doi: 10.1155/2020/5723485. eCollection 2020.

Abstract

OBJECTIVE

To examine the efficacy of vitamin E in methotrexate- (MTX-) induced transaminitis in patients with rheumatoid arthritis (RA).

METHODS

A case-control study was conducted at a tertiary rheumatology center for 12 months. Patients with RA on MTX and deranged aminotransferases were included. Patients with previous liver diseases, baseline transaminitis before methotrexate initiation, alcohol intake, muscle diseases, under hepatotoxic drugs, and > 3 times the upper normal limit were excluded. The patients were divided into treatment (vitamin E 400 mg bid for 3 months) and control groups (no vitamin E) using a random number table. The dose of MTX was unaltered. Follow-up was done after 3 and 6 months. Independent -test was done to compare means of two groups. Paired -test was done to compare differences in mean.

RESULTS

Among 230 patients, 86.5% were female with a mean BMI of 25.9 ± 4.5 kg/m. In the treatment group, SGPT and SGOT at baseline were 73.1 ± 20.4 and 60.2 ± 24.5 IU/L, respectively; at 3-month follow-up 44.6 ± 34.2 and 38.3 ± 20.8 IU/L, respectively; and at 6-month follow-up 40.4 ± 35.7 and 34.2 ± 21.9 IU/L, respectively. In the control group, SGPT and SGOT at baseline were 63.4 ± 15.1 and 46.8 ± 13.7 IU/L, respectively, and at 3-month follow-up 55.8 ± 45.9 and 45.5 ± 30.9 IU/L, respectively. Significant decrease in the level of aminotransferases was seen in the treatment group ( value < 0.001) and not in the control group ( values 0.161 and 0.728, respectively). The change in levels of SGPT and SGOT from baseline to 3 months of follow-up was statistically significant in between two study groups ( values 0.007 and <0.001, respectively). From the control group, 29 patients were crossed over to vitamin E for the next 3 months. SGPT and SGOT decreased from 97.6 ± 44.1 to 46.1 ± 40.9 and 69.3 ± 34.9 to 29.1 ± 11.6 IU/L, respectively ( values 0.031 and 0.017, respectively).

CONCLUSION

Vitamin E significantly attenuates MTX-induced transaminitis.

摘要

目的

探讨维生素E对类风湿关节炎(RA)患者甲氨蝶呤(MTX)所致转氨酶升高的疗效。

方法

在一家三级风湿病中心进行了为期12个月的病例对照研究。纳入使用MTX且转氨酶紊乱的RA患者。排除既往有肝脏疾病、MTX起始治疗前基线转氨酶升高、饮酒、肌肉疾病、正在使用肝毒性药物以及转氨酶高于正常上限3倍以上的患者。使用随机数字表将患者分为治疗组(维生素E 400mg,每日两次,共3个月)和对照组(不使用维生素E)。MTX剂量不变。在3个月和6个月后进行随访。采用独立样本t检验比较两组均值。采用配对t检验比较均值差异。

结果

230例患者中,86.5%为女性,平均体重指数为25.9±4.5kg/m²。治疗组基线时谷丙转氨酶(SGPT)和谷草转氨酶(SGOT)分别为73.1±20.4和60.2±24.5IU/L;3个月随访时分别为44.6±34.2和38.3±20.8IU/L;6个月随访时分别为40.4±35.7和34.2±21.9IU/L。对照组基线时SGPT和SGOT分别为63.4±15.1和46.8±13.7IU/L,3个月随访时分别为55.8±45.9和45.5±30.9IU/L。治疗组转氨酶水平显著下降(P值<0.001),而对照组未下降(P值分别为0.161和0.728)。两个研究组之间从基线到随访3个月时SGPT和SGOT水平的变化具有统计学意义(P值分别为0.007和<0.001)。对照组中有29例患者在接下来的3个月改用维生素E治疗。SGPT和SGOT分别从97.6±44.1降至46.1±40.9以及从69.3±34.9降至29.1±11.6IU/L(P值分别为0.031和0.017)。

结论

维生素E可显著减轻MTX所致的转氨酶升高。

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